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    Senior Medical Information Writer

    Sanofi
    5+ years
    Not Disclosed
    Hyderabad
    10 Oct. 17, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Scientific Response Writer
    Location: [Insert Location]

    Main Responsibilities

    As a Scientific Response Writer, you will research and author scientific response documents under the guidance of the Global Medical Information (GMI) team, supporting both global and local medical information activities. Your role involves a blend of product knowledge, writing, editing, and document management skills.

    Essential Duties and Responsibilities

    1. Conduct literature searches and reviews, summarizing complex data from scientific literature.
    2. Generate evidence-based, accurate, and fair-balanced summaries for scientific response documents related to designated therapeutic areas.
    3. Adapt global scientific response documents for specific countries.
    4. Develop responses to escalated inquiries for assigned countries.
    5. Contribute to US NDA Annual Reports.
    6. Assist in US compendia reviews.
    7. Maintain and develop expertise in assigned Therapeutic Areas.
    8. Review content created by peer writers.
    9. Collaborate effectively with Global Medical Information teams to implement content plans.

    People Management

    • Maintain effective relationships with stakeholders in the medical scientific community to develop relevant medical information content.
    • Interact with medical and pharmacovigilance departments to ensure accurate information flow.
    • Assist fellow medical information writers in enhancing their knowledge and skills.

    Performance

    • Deliver high-quality scientific response documents, US NDA Annual Reports, and US compendia reviews within agreed timelines.

    Process

    1. Act as a medical information writing expert, adhering to regulatory requirements for supported countries.
    2. Assist the medical information team in performing comprehensive writing needs analyses.
    3. Implement relevant content plans and associated activities for assigned countries.
    4. Collaborate with selected vendors to ensure timely delivery of required documents.
    5. Develop an action plan based on stakeholder feedback to enhance content quality.

    Stakeholder Engagement

    • Work closely with medical teams to identify writing needs and assist in developing deliverables.
    • Liaise with the Medical department to prepare customized outputs.

    About You

    • Experience: Over 5 years in medical writing within the pharmaceuticals or healthcare industry, including 2-3 years in direct medical information roles at a pharmaceutical company.
    • Soft Skills: Strong stakeholder management, communication skills, and the ability to work both independently and as part of a team.
    • Technical Skills: Proficient in medical writing, editing, literature evaluation, and multi-level response development.
    • Education: Advanced degree in life sciences, pharmacy, or a related discipline; medical or doctorate degree (PharmD, PhD, Master's, or equivalent) preferred.
    • Languages: Excellent proficiency in English (spoken and written).

    Pursue Progress. Discover Extraordinary.

    Progress doesn’t happen without diverse individuals united by a common goal: to create miracles. Join us in embracing change, exploring new ideas, and pursuing extraordinary opportunities together.

    At Sanofi, we are committed to equal opportunities for all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our One Day at Sanofi video and explore our Diversity, Equity, and Inclusion initiatives at sanofi.com.

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